The recombinant human anti-new coronavirus monoclonal antibody injection (JS016) developed by a Chinese team has been approved by the State Drug Administration to enter Phase I clinical trials.
The team members are from Shanghai Junshi Biomedical Technology Co and the Institute of Microbiology, Chinese Academy of Sciences.
Huashan Hospital affiliated with Fudan University has completed the first subject administration.
This is the world's first clinical trial of a novel therapeutic antibody for coronavirus pneumonia in a healthy population after having completed non-human primate studies, marking the successful entry of a new coronavirus-specific antibody drug with Chinese independent intellectual property rights into human clinical evaluation.
This clinical trial was conducted in a randomized, double-blind, placebo-controlled study to evaluate the tolerability, safety, pharmacokinetic characteristics, and immunogenicity of JS016 administered by intravenous infusion in healthy Chinese volunteers.
Currently, four healthy subjects in the first dose group are in good condition, and the trial will continue to progress in strict accordance with the protocol.
The safety and tolerability data obtained from all healthy subjects will support the selection of appropriate doses for subsequent clinical trials in patients with novel coronavirus infections.
Professor Zhang Wenhong, from Huashan Hospital, said, "Neutralizing antibodies have a unique ability to target novel coronaviruses with precision. It is targeted to prevent the virus from replicating in the human body and produce a rapid effect."
"We hope to demonstrate the good safety and tolerability of JS016 in Phase I to provide data to support subsequent clinical programs. Neutralizing antibody therapy is expected to be the first treatment option against the novel coronavirus."
In addition to its potential therapeutic benefits, previous studies have also shown that neutralizing antibody drugs are effective in preventing viral infections.
Unlike the vaccine, the drug is more suitable for prevention in key populations such as health care workers in intensive care units and the elderly in emergency situations, which is complementary to the vaccine.
JS016 is derived from novel coronavirus pneumonia in patients recovering from the disease.
Researchers at the Institute of Microbiology of the Chinese Academy of Sciences used single-cell sequencing to isolate the new drug from single nucleated cells in patients' peripheral blood. Coronavirus neutralizing monoclonal antibodies; and then using flow cytometry, blocking assay analysis was performed to screen out those with strong neutralizing activity.
Experts say that there is still a long way to go from the human clinical trial stage to the final use of antibody drugs.